ee survival was 4.4 months. Overall survival at 6 months was 74% (95% CI: 62%–86%) and 12-month overall survival was 65% (95% CI: 52%–78%). Median overall survival was 15.9 months.
15 REFERENCES1.OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999.
2.American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172–1193.
3.NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.[3]
4.Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology.
16 HOW SUPPLIED/STORAGE AND HANDLING16.1 Safe Handling and DisposalCare should be exercised in the handling and preparation of TEMODAR. Vials and capsules should not be opened. If vials or capsules are accidentally opened or damaged, rigorous precautions should be taken with the contents to avoid inhalation or contact with the skin or mucous membranes. The use of gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or capsules. Procedures for proper handling and disposal of anticancer drugs should be considered {1–4}. Several guidelines on this subject have been published.
16.2 How SuppliedTEMODAR Capsules:
TEMODAR (temozolomide) Capsules are supplied in amber glass bottles with child-resistant polypropylene caps or child-resistant sachets containing the following capsule strengths:
TEMODAR Capsules 5 mg: have opaque white bodies with green caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with "TEMODAR".
They are supplied as follows:
Bottles:
5-count – NDC 0085-3004-02
14-count – NDC 0085-3004-01
Sachets:
5-count – NDC 0085-3004-03
14-count – NDC 0085-3004-04
TEMODAR Capsules 20 mg: have opaque white bodies with yellow caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with "TEMODAR".
They are supplied as follows:
Bottles:
5-count – NDC 0085-1519-02
14-count – NDC 0085-1519-01
Sachets:
5-count – NDC 0085-1519-03
14-count – NDC 0085-1519-04
TEMODAR Capsules 100 mg: have opaque white bodies with pink caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with "TEMODAR".
They are supplied as follows:
Bottles:
5-count – NDC 0085-1366-02
14-count – NDC 0085-1366-01
Sachets:
5-count – NDC 0085-1366-03
14-count – NDC 0085-1366-04
TEMODAR Capsules 140 mg: have opaque white bodies with blue caps. The capsule body is imprinted with two stripes, the dosage strength, and the Schering-Plough logo. The cap is imprinted with "TEMODAR".
They are supplied as follows:
Bottles:
5-count – NDC 0085-1425-01
14-count – NDC 0085-1425-02
Sachets:
5-count – NDC 008 |
